prevent: promus btk

Conditions: Peripheral Arterial Disease

Summary: this is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. the immediate and long-term (up to 12 months) outcome of the promus element everolimus-eluting stent system (boston scientific) and the promus element plus everolimus-eluting stent system (boston scientific) will be evaluated. in 2 belgian centers, 3 german centers and 1 new zealand center a total of 70 patients will be recruited. primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.


Eligibility criteria:
general inclusion criteria: * patient presenting with rest pain or minor tissue loss (rutherford class 4 or 5) * patient is willing to comply with specified follow-up evaluations at the specified times * patient is \>18 years old * patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * patient has a projected life-expectancy of at least 12 months * the treating physician consider the patient eligible for below-the-knee treatment with the promus element stent (boston scientific) and promus element plus stent (boston scientific) * male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure angiographic inclusion criteria: * single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk * a maximum of two focal target lesions in one or more infrapopliteal vessels * length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted * target vessel diameter visually estimated to be \>2.5mm and \<4.0mm * guidewire and delivery system successfully traversed lesion general exclusion criteria: * patient refusing treatment * previously implanted stent in the artery to be treated * failed pta of target lesion/vessel less than 3 months prior to study procedure * the reference segment diameter is not suitable for the available stent design * untreated flow-limiting inflow lesions * perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment * any previous surgery in the target vessel (including prior ipsilateral crural bypass) * aneurysm in the target vessel * patient presents with renal failure, evidenced by a serum creatinine level \>2.0mg/dl * patient presents with platelet levels above or below normal range * non-atherosclerothic disease resulting in occlusion (e.g. embolism, buerger's disease, vasculitis) * severe medical comorbidities (untreated cad/chf, severe copd, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy * major distal amputation (above the transmetatarsal) in the study limb or non-study limb * septicemia or bacteremia * any previously known coagulation disorder, including hypercoagulability * contraindication to anticoagulation or antiplatelet therapy * known allergies to stent or stent components * known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure * patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (hit) type ii * currently participating in another clinical research trial * angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment * target lesion access not performed by transfemoral approach.

Keywords: peripheral arterial disease claudication drug-eluting stent btk everolimus cli